Colon Cancer Stage INCT05421702
Comparison Between Results of 2 Laparoscopic Surgical Procedures in Operable Colon Cancer Cases in Upper Egypt
A study testing laparoscopic conventional colectomy and laparoscopic complete mesocolic excision in people with Colon Cancer Stage I and Colon Cancer Stage II, run by Sohag University at 1 site in Egypt.
Trial summary
The investigators will assess and compare Surgical, pathological and oncological outcomes between two laparoscopic procedures conventional colectomy versus complete mesocolic excision for operable colon cancer cases in Upper Egypt Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colon Cancer Stage I, Colon Cancer Stage II
- What is being tested?
- laparoscopic conventional colectomy and laparoscopic complete mesocolic excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2022to 21 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Both sexes will be included.
- Age: all adult patients.
- All diagnosed patients with operable cancer colon.
- Cancer at cecum, appendix, ascending colon, hepatic flexure or at splenic flexure, transverse and descending colon and sigmoid colon.
- Fit patients.
Who cannot join
- Irresectable colon cancer.
- Inoperable colon cancer.
- Rectal cancer.
- Unfit patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical, Pathological and Oncological Outcomes of Laparoscopic Conventional Colectomy Versus Complete Mesocolic Excision for Operable Colon Cancer Cases in Upper Egypt
The investigators will assess and compare Surgical, pathological and oncological outcomes between two laparoscopic procedures conventional colectomy versus complete mesocolic excision for operable colon cancer cases in Upper Egypt
Read the detailed description
Colon cancer is considered a huge clinical surgical burden accounting for 10% of cancer cases and deaths all over the world with consideration that surgery and adjuvant chemotherapy(if indicated) are the main lines of treatment .
When Werner Hohenberger and colleagues described complete mesocolic excision (CME) in 2009; resection along the embryological and lymphovascular planes with appropriate resection margins, they did it for years before describing it with suggestion of improved disease outcomes and overall survival compared to the conventional colectomy (CC).
The principles of CME were described after the significant improvement of rectal adenocarcinoma surgical outcomes with establishment of total mesorectal excision (TME) in which tumor resection is associated with dissection of mesorectal fascial embryologic and lymphovascular planes.
CME includes the same principles of the CC with maximizing lymph node dissection level into (D3 extended lymphadenectomy instead of D1 and D2 in conventional colectomy) and central vascular ligation (CVL) of the main feeding vessel(s) at their origin, with suggested improved disease-free and overall survival with suggested superior pathological and oncological results in the specimen.
Some surgeons consider that CME; with D3 extended lymphadenectomy and CVL is the optimal or standard surgical method in primary cancer colon based on suggested reduced local recurrence and improved disease-free and overall survival.
Although CME has a theoretical advantages and promising early results, it is not widely adopted as the standard in some areas. CME is technically more demanding than CC and suggested to be associated with more intraoperative visceral injuries and non-surgical complications and many doubts persist about safety and efficacy of the procedure.
The questions of interest and research, should CME be regarded as the optimal procedure for colon cancer cases? And also another question; is conventional colectomy suboptimal?
- Conditions
- Colon Cancer Stage I, Colon Cancer Stage II
- Being tested
- laparoscopic conventional colectomy, laparoscopic complete mesocolic excision
- Keywords
- Colon cancer, Colectomy, Mesocolic, Conventional, Laparoscopic, Surgical, Pathological
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic conventional colectomyProcedure or surgery
Also called D2 colectomy
Laparoscopic colectomy with only lymph node dissection up to level 2 lymph nodes D2.
laparoscopic complete mesocolic excisionProcedure or surgery
Laparoscopic colectomy with lymphovascular dissection from level 3 lymph nodes or more D3.
| Study group | Role | What they receive |
|---|---|---|
| Group A Operable colon cancer cases | Active comparator | All patients with operable colon cancer who will undergo laparoscopic conventional colectomy Receives: Procedure: laparoscopic conventional colectomy |
| Group B Operable colon cancer cases | Active comparator | All patients with operable colon cancer who will undergo laparoscopic complete mesocolic excision Receives: Procedure: laparoscopic complete mesocolic excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative lymph node status
Histopathological examination of the resected colon with lymph node status and number
Measured: 2 weeks postoperative
Postoperative histopathological result
Type of the colon cancer
Measured: 2 weeks postoperative
Occurence of anastomotic leak
Yes/No
Measured: within 4 weeks postoperative
Amount of anastomotic leak
Amount in cubic cm and nature of it with its management
Measured: within 4 weeks postoperative
Intraoperative visceral injury type
Yes/No and its type
Measured: Intraoperative reporting
Intraoperative visceral injury management
How managed
Measured: Intraoperative reporting
Postoperative complications
Yes/No with Reporting the postoperative complications; according to the Clavien-Dindo Grading System
Measured: 4 weeks postoperative
Operative time
Reporting operative time with measurements in minutes
Measured: Reporting immediately postoperative (at end of operation)
Intraoperative vascular injury
Yes/No with measurement in Cubic Cm and how managed
Measured: Intraoperative
Intraoperative blood loss
Yes/No with measurement in Cubic Cm
Measured: Intraoperative
Resection margins in postoperative histopathological status
Free or invaded
Measured: 2 weeks postoperative
Postoperative peritonitis
Cause and how to manage?
Measured: 4 weeks postoperative
Colon cancer stage
According to primary tumor, regional nodes, metastasis (TNM) staging system
Measured: 2 weeks Preoperative
Postoperative faecal fistula
Reporting Yes/No with amount in cm3 and management
Measured: 12 weeks postoperative
length of resected mesocolon
In cm
Measured: 2 weeks postoperative
Urological complications
Type and management
Measured: Intraoperative and 4 weeks postoperative
Carcinoembryonic antigen (CEA) level
Carcinoembryonic antigen (CEA) level by ng/mL
Measured: 2 weeks preoperative
Type of anastomosis
Type of anastomosis (intra- or extracorporeal)
Measured: Intraoperative
Secondary outcomes (18)
Age
In years
Measured: preoperative
Preoperative haemoglobin level
measured by g/dl
Measured: preoperative
Type of colonic anastomosis
Stapler or hand sewing
Measured: Intraoperative
Preoperative histopathological result
Histopathological examination
Measured: 2 weeks preoperative
Neoadjuvant therapy
Type of the neoadjuvant and duration
Measured: 2 weeks Preoperative
Site of cancer colon
cecum, appendix, ascending colon, hepatic flexure or at splenic flexure, transverse and descending colon and sigmoid colon
Measured: 2 weeks preoperative
Neurological complications
Type and management
Measured: 4 weeks postoperative
Preoperative preparation
Mechanical and/or chemical
Measured: 3 days Preoperative
Cardiopulmonary complications
Yes/No Cardiopulmonary complications type and how managed
Measured: 4 weeks postoperative
Conversion to open surgery
Yes/No with the cause
Measured: intraoperative
application of subcutaneous suction
Yes/No
Measured: 1 week Postoperative
Average daily amount in subcutaneous suction
in Milliliters
Measured: 2 weeks Postoperative
Average daily amount in intraperitoneal drain
in Milliliters
Measured: 2 weeks Postoperative
Wound infection
Yes/No and how managed
Measured: 2 weeks postoperative
Postoperative ileus
Postoperative ileus Yes/No
Measured: 2 weeks postoperative
Hospital stay
In days
Measured: 4 weeks postoperative
Wound dehiscence
Yes/No
Measured: 4 weeks postoperative
Preoperative colonoscopic examination result
mass/ulcer
Measured: 2 weeks preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start1 Jul 2022
- Primary completion24 Apr 2024
- Study completion21 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Cancer Stage IStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Operable colon cancer cases
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Farrag Mohammed, Sohag University
- Investigators
- Ahmed E Ahmed, Professor, Study chair, Sohag UniversityMena Z Helmy, Ass prof., Study director, Sohag UniversityMostafa F Mohammed, Ass lecturer, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421702
- Sponsor's protocol ID
- Soh-Med-22-06-17
- Status last verified
- Feb 2026
- First submitted
- 13 Jun 2022
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical, Pathological and Oncological Outcomes of Laparoscopic Conventional Colectomy Versus Complete Mesocolic Excision for Operable Colon Cancer Cases in Upper Egypt
- ClinicalTrials.gov ID
- NCT05421702
- Acronym / sponsor ID
- Soh-Med-22-06-17
- Conditions
- Colon Cancer Stage I, Colon Cancer Stage II
- Keywords
- Colon cancer, Colectomy, Mesocolic, Conventional, Laparoscopic, Surgical, Pathological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 21 Jul 2024 (actual)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will assess and compare Surgical, pathological and oncological outcomes between two laparoscopic procedures conventional colectomy versus complete mesocolic excision for operable colon cancer cases in Upper Egypt
Detailed description
Colon cancer is considered a huge clinical surgical burden accounting for 10% of cancer cases and deaths all over the world with consideration that surgery and adjuvant chemotherapy(if indicated) are the main lines of treatment .
When Werner Hohenberger and colleagues described complete mesocolic excision (CME) in 2009; resection along the embryological and lymphovascular planes with appropriate resection margins, they did it for years before describing it with suggestion of improved disease outcomes and overall survival compared to the conventional colectomy (CC).
The principles of CME were described after the significant improvement of rectal adenocarcinoma surgical outcomes with establishment of total mesorectal excision (TME) in which tumor resection is associated with dissection of mesorectal fascial embryologic and lymphovascular planes.
CME includes the same principles of the CC with maximizing lymph node dissection level into (D3 extended lymphadenectomy instead of D1 and D2 in conventional colectomy) and central vascular ligation (CVL) of the main feeding vessel(s) at their origin, with suggested improved disease-free and overall survival with suggested superior pathological and oncological results in the specimen.
Some surgeons consider that CME; with D3 extended lymphadenectomy and CVL is the optimal or standard surgical method in primary cancer colon based on suggested reduced local recurrence and improved disease-free and overall survival.
Although CME has a theoretical advantages and promising early results, it is not widely adopted as the standard in some areas. CME is technically more demanding than CC and suggested to be associated with more intraoperative visceral injuries and non-surgical complications and many doubts persist about safety and efficacy of the procedure.
The questions of interest and research, should CME be regarded as the optimal procedure for colon cancer cases? And also another question; is conventional colectomy suboptimal?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Operable colon cancer cases
| Arm | Type | Receives |
|---|---|---|
| Group A Operable colon cancer cases | Active comparator | Procedure: laparoscopic conventional colectomyAll patients with operable colon cancer who will undergo laparoscopic conventional colectomy |
| Group B Operable colon cancer cases | Active comparator | Procedure: laparoscopic complete mesocolic excisionAll patients with operable colon cancer who will undergo laparoscopic complete mesocolic excision |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Both sexes will be included.
- Age: all adult patients.
- All diagnosed patients with operable cancer colon.
- Cancer at cecum, appendix, ascending colon, hepatic flexure or at splenic flexure, transverse and descending colon and sigmoid colon.
- Fit patients.
Key exclusion criteria (4 listed)
- Irresectable colon cancer.
- Inoperable colon cancer.
- Rectal cancer.
- Unfit patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic conventional colectomyAlso: D2 colectomyLaparoscopic colectomy with only lymph node dissection up to level 2 lymph nodes D2. | Procedure or surgery | Group A Operable colon cancer cases |
| laparoscopic complete mesocolic excisionLaparoscopic colectomy with lymphovascular dissection from level 3 lymph nodes or more D3. | Procedure or surgery | Group B Operable colon cancer cases |
Primary outcome
Postoperative lymph node status
Time frame: 2 weeks postoperative
Histopathological examination of the resected colon with lymph node status and number
Postoperative histopathological result
Time frame: 2 weeks postoperative
Type of the colon cancer
Occurence of anastomotic leak
Time frame: within 4 weeks postoperative
Yes/No
Amount of anastomotic leak
Time frame: within 4 weeks postoperative
Amount in cubic cm and nature of it with its management
Intraoperative visceral injury type
Time frame: Intraoperative reporting
Yes/No and its type
Intraoperative visceral injury management
Time frame: Intraoperative reporting
How managed
Postoperative complications
Time frame: 4 weeks postoperative
Yes/No with Reporting the postoperative complications; according to the Clavien-Dindo Grading System
Operative time
Time frame: Reporting immediately postoperative (at end of operation)
Reporting operative time with measurements in minutes
Intraoperative vascular injury
Time frame: Intraoperative
Yes/No with measurement in Cubic Cm and how managed
Intraoperative blood loss
Time frame: Intraoperative
Yes/No with measurement in Cubic Cm
Resection margins in postoperative histopathological status
Time frame: 2 weeks postoperative
Free or invaded
Postoperative peritonitis
Time frame: 4 weeks postoperative
Cause and how to manage?
Colon cancer stage
Time frame: 2 weeks Preoperative
According to primary tumor, regional nodes, metastasis (TNM) staging system
Postoperative faecal fistula
Time frame: 12 weeks postoperative
Reporting Yes/No with amount in cm3 and management
length of resected mesocolon
Time frame: 2 weeks postoperative
In cm
Urological complications
Time frame: Intraoperative and 4 weeks postoperative
Type and management
Carcinoembryonic antigen (CEA) level
Time frame: 2 weeks preoperative
Carcinoembryonic antigen (CEA) level by ng/mL
Type of anastomosis
Time frame: Intraoperative
Type of anastomosis (intra- or extracorporeal)
18 secondary outcomes
Age
Time frame: preoperative
Preoperative haemoglobin level
Time frame: preoperative
Type of colonic anastomosis
Time frame: Intraoperative
Preoperative histopathological result
Time frame: 2 weeks preoperative
Neoadjuvant therapy
Time frame: 2 weeks Preoperative
Site of cancer colon
Time frame: 2 weeks preoperative
Neurological complications
Time frame: 4 weeks postoperative
Preoperative preparation
Time frame: 3 days Preoperative
Cardiopulmonary complications
Time frame: 4 weeks postoperative
Conversion to open surgery
Time frame: intraoperative
application of subcutaneous suction
Time frame: 1 week Postoperative
Average daily amount in subcutaneous suction
Time frame: 2 weeks Postoperative
Average daily amount in intraperitoneal drain
Time frame: 2 weeks Postoperative
Wound infection
Time frame: 2 weeks postoperative
Postoperative ileus
Time frame: 2 weeks postoperative
Hospital stay
Time frame: 4 weeks postoperative
Wound dehiscence
Time frame: 4 weeks postoperative
Preoperative colonoscopic examination result
Time frame: 2 weeks preoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No. It is not yet known if there will be a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed E Ahmed, Professor study chair
Sohag University
Mena Z Helmy, Ass prof. study director
Sohag University
Mostafa F Mohammed, Ass lecturer principal investigator
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic conventional colectomy and laparoscopic complete mesocolic excision in people with Colon Cancer Stage I and Colon Cancer Stage II, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative lymph node status (time frame: 2 weeks postoperative). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.